John Wiley & Sons Fundamentals of Drug Development Cover Fundamentals of DRUG DEVELOPMENT Enables readers to understand the process of pharmaceutical resear.. Product #: 978-1-119-69169-3 Regular price: $101.87 $101.87 Auf Lager

Fundamentals of Drug Development

Barrett, Jeffrey S.


1. Auflage November 2022
512 Seiten, Hardcover

ISBN: 978-1-119-69169-3
John Wiley & Sons

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Fundamentals of DRUG DEVELOPMENT

Enables readers to understand the process of pharmaceutical research, its regulatory basis, and how it fits into the global healthcare environment

This book discusses how to conduct pharmaceutical research and the context for how the industry fits into global healthcare. Holistically, the well-qualified author helps readers and students of drug development appreciate the time and expense of the process. Specifically, the work identifies the emerging trends shaping the future of drug development, along with important related topics like generic drugs, data sharing, and collaboration.

To aid in seamless reader comprehension, the book includes a glossary of terms and a self-assessment quiz for each chapter at the end. PowerPoint slides are also available as an online ancillary for adopting professors. Sample topics covered in the book include:
* Drug development and its phases
* Decision-making processes, drug development milestones, and compound progression metrics
* The various disciplines involved along with an assessment of the complexity and risks associated across the stages of development
* Differences in the nature and scope of development programs due to the therapeutic area of interest
* Associated costs and resources required

Graduate students and professors teaching courses in drug development, drug discovery, pharmaceuticals, medicinal chemistry, and drug synthesis will be able to use this book as a complete resource for understanding all the complexities and nuances involved in the drug development process.

Preface and Introduction

Chapter 1: The History of Drug Development

Chapter 2: The Modern Pharmaceutical Industry: Big and Small Pharma, Biotechnology Companies, and Generic Drug Makers

Chapter 3: Legal Considerations, Intellectual Property, Patents and Patent Protection

Chapter 4: The Global Regulatory Landscape

Chapter 5: Phases of Drug Development: Old and New Paradigms

Chapter 6: Discovery / Preclinical

Chapter 7: Phase I

Chapter 8: Phase II

Chapter 9: Phase III

Chapter 10: Phase IV, Special Populations and Post Marketing Commitments

Chapter 11: Role and Function of Project Teams

Chapter 12: Compound Progression and Go / No Go Criteria

Chapter 13: Regulatory Milestones and the Submission Process

Chapter 14: Life Cycle Management

Chapter 15: Formulation Development

Chapter 16: Chemistry and Manufacturing (CMC)

Chapter 17: Health Economics and the Healthcare Industry

Chapter 18: Current State of Affairs: Attrition Rates and Evolving Corporate Strategies

Chapter 19: Medical Devices

Chapter 20: Distribution and the Supply Chain

Chapter 21: Sales, Marketing and Advertising

Chapter 22: Generic Drugs and the Generic Industry

Chapter 23: The Generic Approval Process

Chapter 24: Data Sharing and Collaboration

Chapter 25: The Future of the Pharmaceutical Industry


Chapter Self-Assessments and Quiz
Jeffrey S. Barrett, PhD, is the Chief Science Officer at Aridhia Digital Research Environment promoting life science partners to collaborate, access and share secure data to deliver better patient outcomes. He has over 30 years' experience in pharmaceutical research and development, 13 of which were spent in the industry (1990 - 2003) followed by over 10 years (2001 -13) at the University of Pennsylvania and The Children's Hospital of Philadelphia and then back to industry at Sanofi Pharmaceuticals (2013 -17) while still serving as an adjunct faculty member at University of Pennsylvania.

J. S. Barrett, University of Pennsylvania